NCT00737984

Brief Summary

Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 20, 2012

Status Verified

October 1, 2009

Enrollment Period

3 years

First QC Date

August 18, 2008

Last Update Submit

April 19, 2012

Conditions

Keywords

InfertilityClinical pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • The rate of clinical pregnancy

    24 months

Study Arms (2)

1

NO INTERVENTION

Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling

2

ACTIVE COMPARATOR

Group 2 patients will receive standard superovulation-IUI treatment with endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle

Procedure: Endometrial sampling

Interventions

Endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle

Also known as: Intrauterine insemination, Clinical pregnancy rate
2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women undergoing superovulation with gonadotrophins and intrauterine insemination.
  • All women with cervical factor, mild male factor and/or unexplained infertility.
  • At least one patent Fallopian tube.

You may not qualify if:

  • Bilateral tubal disease
  • Severe male factor infertility
  • Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions)
  • Women with positive cervical culture and/or acute vaginal infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (2)

  • Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.

    PMID: 17197286BACKGROUND
  • Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Togas Tulandi, MD, MHCM

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Reproductive Endocrinology and Infertility

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 20, 2012

Record last verified: 2009-10

Locations